Brillant Blue Versus Indocyanine Green for Macular Hole Surgery

Idiopathic Macular Holes Clinical Trial

Official title:

Membranepeeling With Brillant Blue Versus Membranepeeling With Indocyanine Green for Patients With Idiopathic Macular Holes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757471
• Other study ID #: FR-5-CI-2008
• Status: Completed
• Phase: N/A
• First received: September 21, 2008
• Last updated: January 24, 2016
• Start date: August 2008
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Macular Hole Surgery with two different Dyes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic stage 3 and 4 macular holes

• Stage 2 macular holes, followed up for at least 6 months

• Pseudophakic and phakic eyes

• Age over 60 years

Exclusion Criteria:

• Traumatic macular holes

• Secondary macular holes

• Severe ocular diseases

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Brillant Blue
Membrane Peeling with Brillant Blue
• Indocyanine Green
Membrane Peeling with indocyanine Green

Locations

Country	Name	City	State
Austria	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular Hole Closure Rate		12 Months	Yes
Secondary	Visual Acuity Microperimetry Optical Coherence Tomography		12 Months	Yes